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S-ROM 54-0005Recalls & reported problems

Depuy (Ireland) · S-ROM TRIANGLE MILLER SHELL SIZE 5 · Class 1

All models of S-ROM (185)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295173540), received between Nov 21, 2017 and Nov 21, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Bent1
  • Misconnection1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 21, 2017Bent; Misconnection; Bent; Misconnection

    COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE SROM MILLER SHELL IS BENT AND T-HANDLE FRAME NO LONGER FITS. IT WAS ALSO REPORTED THAT IT DID NOT BREAK INTO PIECES AND EVERYTHING WAS RETRIEVED.THE SURGERY WAS NOT DELAYED.

    Patient problems: No Consequences Or Impact To Patient; No Information

    MAUDE report 7050314 ↗

Other REAMER devices

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Sources and updates

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